IEC 62304 Templates

The IEC 62304 describes how to develop and document software for medical devices. This is an overview over our free templates which we’ve published for this standard so far. In other words, if you use these templates, you have a pretty good chance of being compliant with the IEC 62304 :) Enjoy!

The best news is that we’ve published all our templates for this IEC standard for free! Check them out below.

Also note that we have many more templates besides the ones for the IEC 62304 – head over to our templates page for more templates.

And finally, do you want to draft your own QMS with just one click? With Formwork, our eQMS software, combined with our free templates and a little bit of ChatGPT magic, you can draft your QMS in minutes. Check out the video below to see how it works.